Cleared Traditional

K891154 - SPQ(TM) ANTIBODY REAGENT SET II FOR APO...

K891154 is the FDA 510(k) clearance for SPQ(TM) ANTIBODY REAGENT SET II FOR APO... by Atlantic Antibodies. It is a Class 1 Immunology device (product code MSJ) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K891154 · Atlantic Antibodies · Immunology device
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Mar 1989
Decision
10d
Days
Class 1
Risk

K891154 is an FDA 510(k) clearance for the SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Atlantic Antibodies (Scarborough, US). The FDA issued a Cleared decision on March 16, 1989 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1475 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Atlantic Antibodies devices

Submission Details

510(k) Number K891154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1989
Decision Date March 16, 1989
Days to Decision 10 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 104d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MSJ Apolipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MSJ Apolipoproteins

All 31
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K891154.
ROCHE REAGENT FOR APOLIPOPROTEIN A-1
K910551 · Roche Diagnostic Systems, Inc. · May 1991
ROCHE REAGENT FOR APOLIPOPROTEIN B
K910552 · Roche Diagnostic Systems, Inc. · May 1991
BACTON TM, BASIC TM, APO B REAGENT
K893884 · Catachem, Inc. · Jun 1989
QM300 APOLIPOPROTEIN A-I ANTIBODY PACK
K883713 · Kallestad Diag, A Div. of Erbamont, Inc. · Oct 1988
QM300 APOLIPOPROTEIN B ANTIBODY PACK
K883714 · Kallestad Diag, A Div. of Erbamont, Inc. · Oct 1988
TECHNICON DPA-1 APOLIPOPROTEIN B
K883491 · Technicon Instruments Corp. · Sep 1988